Acute Lymphoblastic LeukaemiaPhase 2UKALL60+NCT01616238
A Study for Older Adults With Acute Lymphoblastic Leukaemia
A Phase 2 study testing Chemotherapy in people with Acute Lymphoblastic Leukaemia, run by University College, London at 34 sites in 2 countries.
Trial summary
The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukaemia
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Dec 2012to 1 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
- Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
- Willing and able to give consent
Who cannot join
- Known HIV infection
- Blast transformation of CML
- Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
- Women who are pregnant or lactating
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United Kingdom33 sites
NHS Lanarkshire - Monklands
Airdrie
Blackpool Victoria Hopsital
Blackpool
Royal Bournemouth Hospital
Bournemouth
Bradford Royal Infirmary
Bradford
Bristol Haematology and Oncology Centre
Bristol
University Hospital of Wales
Cardiff
Castle Hill Hospital
Cottingham
Russells Hall Hospital
Dudley
Ninewells Hospital
Dundee
NHS Lothian - Western General Hospital
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
New Victoria Hospital and Southern General Hospital
Glasgow
Northwick Park Hospital
Harrow
St James' Hospital, Leeds
Leeds
Leicester Royal Infirmary
Leicester
Royal Liverpool University Hospital
Liverpool
King's College Hospital NHS Foundation Trust
London
St Bartholomew's Hospital
London
St George's Hospital
London
The Christie Hospital
Manchester
Arrowe Park Hospital
Metropolitan Borough of Wirral
James Cook University Hospital
Middlesbrough
Churchill Hospital, Oxford
Oxford
Derriford Hospital
Plymouth
Poole General Hospital
Poole
St Helen's & Knowlsey Teaching Hospitals
Prescot
Salisbury District Hospital
Salisbury
Royal Hallamshire Hospital
Sheffield
Royal MarsdenHospital
Sutton
Great Western Hospital
Swindon
Musgrove Park
Taunton
Torbay Hospital
Torquay
Sandwell General Hospital
West Bromwich
About this study
Official title: A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
Read the detailed description
The study will
- establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
- disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
- establish national standards of care for this patient group;
- provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
- Conditions
- Acute Lymphoblastic Leukaemia
- Being tested
- Chemotherapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
| Study group | Role | What they receive |
|---|---|---|
| Philadelphia Positive Patients | Experimental | All patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen Receives: Drug: Chemotherapy |
| Philadelphia -ve Patients- Intensive | Experimental | Patients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group. Receives: Drug: Chemotherapy |
| Philadelphia -ve Patients- Intensive + | Experimental | Patients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group Receives: Drug: Chemotherapy |
| Philadelphia -ve Patients- Non Intensive | Experimental | Patients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group Receives: Drug: Chemotherapy |
| Registration only | No intervention | Patients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate after 2 phases of induction
All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated.
Measured: Approximately 2 months after start of treatment
Secondary outcomes (7)
Complete remission rate after 1 phase of induction
All patients will be assessed for their remission status at the end of Phase 1 induction. The CR rate at this timepoint will then be calculated.
Measured: Approximately 1 month after start of treatment
Overall Survival at 1 year
Overall survival for all patients will be measured 1 year after registration
Measured: 1 year after registration
Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
MRD levels will be measured at distinct timepoints during the trial.
Measured: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment
Tolerability of treatment as determined by occurrence of key adverse effects
Patients in arms A-D will be assessed for adverse events at distinct timepoints during the trial
Measured: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment
Duration of in-patient hospitalisation
All patients will be assessed for the number of days they have spent as in-patients at distinct timepoints during the trial.
Measured: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance
Relationship between performance status/co-morbidity and treatment option chosen
Measured: At registration
Quality of life aspects assessed at diagnosis/baseline at various time points
Measured: Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startDec 2012
- Primary completion21 Dec 2018
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukaemiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland
- Responsible party
- Sponsor
- Investigators
- Prof Adele Fielding, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616238
- Sponsor's protocol ID
- UCL/11/0532
- Acronym
- UKALL60+
- Status last verified
- Aug 2023
- First submitted
- 7 Jun 2012
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study for Older Adults With Acute Lymphoblastic Leukaemia
- ClinicalTrials.gov ID
- NCT01616238
- Acronym / sponsor ID
- UKALL60+ / UCL/11/0532
- Conditions
- Acute Lymphoblastic Leukaemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, Stichting Hemato-Oncologie voor Volwassenen Nederland
- Study start
- Dec 2012
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.
Detailed description
The study will
- establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
- disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
- establish national standards of care for this patient group;
- provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Philadelphia Positive Patients | Experimental | Drug: ChemotherapyAll patients with Philadelphia positive ALL will be treated in this group and will receive a standard imatinib-containing chemotherapy regimen |
| Philadelphia -ve Patients- Intensive | Experimental | Drug: ChemotherapyPatients with Philadelphia negative ALL who are fit for intensive treatment will be allocated into this group. |
| Philadelphia -ve Patients- Intensive + | Experimental | Drug: ChemotherapyPatients with Philadelphia negative disease and who are fit for intensive treatment will be entered into this group |
| Philadelphia -ve Patients- Non Intensive | Experimental | Drug: ChemotherapyPatients with Philadelphia negative disease who are not fit for intensive chemotherapy will be entered into this group |
| Registration only | No intervention | –Patients with either Philadelphia positive or negative ALL who do not wish to enter the study will be allocated to this group for data collection purposes only. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
- Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
- Willing and able to give consent
Key exclusion criteria (4 listed)
- Known HIV infection
- Blast transformation of CML
- Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
- Women who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyTreatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years. | Drug | Philadelphia -ve Patients- Intensive, Philadelphia -ve Patients- Intensive +, Philadelphia -ve Patients- Non Intensive, Philadelphia Positive Patients |
Primary outcome
Complete remission rate after 2 phases of induction
Time frame: Approximately 2 months after start of treatment
All patients will be assessed for their remission status at the end of Phase 2 induction. The CR rate at this timepoint will then be calculated.
7 secondary outcomes
Complete remission rate after 1 phase of induction
Time frame: Approximately 1 month after start of treatment
Overall Survival at 1 year
Time frame: 1 year after registration
Prognostic significance of molecularly determined minimal residual disease (MRD) at various time-points during therapy with respect to relapse occurrence.
Time frame: At diagnosis, 4 weeks, 8 weeks, 12 weeks after starting treatment
Tolerability of treatment as determined by occurrence of key adverse effects
Time frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks after starting treatment
Duration of in-patient hospitalisation
Time frame: Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment and every 3 months during maintenance
Relationship between performance status/co-morbidity and treatment option chosen
Time frame: At registration
Quality of life aspects assessed at diagnosis/baseline at various time points
Time frame: Registration, Approximately 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28 after starting treatment, before starting maintenance and at the end of maintenance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Adele Fielding principal investigator
University College London Hospitals
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy in people with Acute Lymphoblastic Leukaemia, run by University College, London at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate after 2 phases of induction (time frame: Approximately 2 months after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.